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Terason uSmart3300 Roller Bag

by Teratech Corporation

Terason uSmart3300 Roller Bag is a hand-held ultrasound imaging system (FDA Class II) made by Teratech Corporation, listed in FDA GUDID since 6 Apr 2018 (UDI-DI 00852698007171), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852698007171 UDI-DI Date6 Apr 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Terason
Generic name
Hand-held ultrasound imaging system, body-surface
Model / reference
uSmart3300 Roller Bag
Primary DI / UDI-DI
00852698007171
FDA product code
IYN, IYO, ITX
GMDN term
Hand-held ultrasound imaging system, body-surface
Device class
Class II
Regulation number
892.1550, 892.1560, 892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hand-held ultrasound imaging system, body-surface

Similar devices in this category

Other devices filed under Hand-held ultrasound imaging system, body-surface.

Other devices from Teratech Corporation

See all devices from Teratech Corporation →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)